该研究的目的是评估间歇性禁食(IF)是否是一种有效的预防措施,以及健康志愿者在日常条件下是否可行。
对健康志愿者进行了为期8周的IF非随机对照临床试验,以及随后4个月的后续行动。结果在基线评估,8周后,6个月后对禁食不感兴趣的志愿者作为对照组。禁食组的参与者被要求在非禁食日继续他们的常规营养习惯,而对照组在整个期间保持习惯性营养。结果包括代谢参数的变化(胰岛素,葡萄糖,胰岛素抵抗,胰岛素样生长因子-1,脑源性神经营养因子,脂质,肝酶,血红蛋白A1c)和凝血标志物;生物电阻抗分析;体重指数;腹围;血压;一般生活质量(5项世界卫生组织福祉指数[WHO-5]问卷),以及情绪和焦虑(医院焦虑和抑郁量表[HADS],情绪状态简介,蓬勃发展的规模,视觉模拟量表,李克特音阶)。干预包括禁食日,每周重复8周,在最低00:00至23:59之间禁欲固体食物,每个禁食日的最大热量摄入量为300千卡。进行了符合方案的分析。P<0.05被认为是显著的。
36名志愿者被包括在内;22名志愿者被分配到禁食组,和14个对照组。最终分析包括33个数据集。尽管在8周和6个月后,两组的许多结局都观察到了显著的组内变化,8周后,除了总体体脂质量以外,其他任何结果以及6个月后的HADS总分和WHO-5总分均无显著组间差异,都赞成禁食组。然而,组间差异均无临床相关性.
在健康志愿者中进行8周的IF对照临床试验中,我们没有发现两组之间的任何临床相关差异。该领域的进一步临床研究有必要进一步分析IF的机制和作用。
The aim of the study was to evaluate whether intermittent fasting (IF) is an effective preventive measure, and whether it is feasible for healthy volunteers under every day conditions.
A nonrandomized controlled clinical trial on IF was performed with healthy volunteers over a period of 8 wk, and a subsequent 4-mo follow-up. Outcomes were assessed at baseline, after 8 wk, and after 6 mo. Volunteers who were not interested in fasting served as a control group. Participants in the fasting group were asked to continue their regular nutritional habits on the nonfasting days, whereas the control group maintained their habitual nutrition throughout the whole period. Outcomes included changes of metabolic parameters (insulin, glucose, insulin resistance, insulin-like growth factor-1, brain-derived neurotropic factor, lipids, liver enzymes, hemoglobin A1c) and coagulation markers; bioelectrical impedance analysis; body mass index; abdominal girth; blood pressure; general quality of life (five-item World Health Organization Well-Being Index [WHO-5] questionnaire), as well as mood and anxiety (Hospital Anxiety and Depression Scale [HADS], Profile of Mood States, Flourishing-Scale, visual analog scale, Likert scales). The intervention consisted of a fasting day, which was repeated every week for 8 wk, with abstinence from solid food between 00:00 and 23:59 at minimum and a maximum caloric intake of 300 kcal on each fasting day. A per-protocol analysis was performed. P < 0.05 was considered significant.
Thirty-six volunteers were included; 22 allocated themselves to the fasting group, and 14 to the control group. Thirty-three data sets were included in the final analysis. Although significant in-group changes were observed in both groups for a number of outcomes after 8 wk and 6 mo, no significant between-group differences were observed for any outcome other than overall body fat mass after 8 wk as well as for the HADS total score and the WHO-5 total score after 6 mo, all in favor of the fasting group. However, none of the between-group differences were clinically relevant.
We did not find any clinically relevant differences between groups in this controlled clinical pilot trial of 8 wk of IF in healthy volunteers. Further clinical research in this field is warranted to further analyze mechanisms and effects of IF.